Position Summary?Implement RA operation strategy & plan in China to drive RA/CA excellence.?Requirements1.??????Education：Bachelor's degree or above in science and engineering through unified enrollment2.??????Experience：Fresh graduates with outstanding performance are accepted, or those with 2-3 years of relevant ex-perience in QA, registration, compliance, and quality system in the medical device industry.?Other skills1.??????Computer skills (MS Office products, word processing, spreadsheets, etc.)2.??????Good English reading and writing skills, capable of independently writing English emails, reviewing registration materials, and having basic oral communication skills, able to cooperate with interna-tional teams to complete simple meetings.3.??????Good analyse and problem solving skill, be able to flexibly adjust strategies in the face of emergen-cies4.??????High attention to detail and accuracy.5.??????Good at internal and external communication6.??????Can manage multiple concurrent tasks simultaneously.7.??????Responsible, able to ensure tasks are completed with high quality and on time.8.??????Respectful, stable.9.??????International company experiences preferred10.????Good knowledge of medical device regulation preferred?Job De****ionMain Tasks1.??????Involved in establishing RA operation strategy & plan in China to drive RA/CA operation excellence, analyzing the gaps and needs together with global and local team for China RA/CA, optimizing local submission management process to enable effective registration and approval in China.2.??????Involved in providing operational expertise to RA/CA teams for quality preparation and execution & approval.3.??????Involved in setting up and maintaining regulatory processes (WI, SOPs) for China RA/CA compliance and in align-ment with global procedures whenever necessary.4.??????Involved in driving and working with RA/CA to identify process improvement areas, develop and update local working processes.5.??????Perform registration extension, communicate with Marketing and Global, secure no gap.6.??????Maintain and update regulation, guidance database, industry data, etc., and deliver these documents to relevant departments or people as requested.7.??????Collaborate with QA/logistics/Marketing team for Chinse label and IFU creation, review and release according to relevant processes and regulation to drive compliance, as well as IFU change notification.8.??????Maintain the submission documents, certificate, PTR and test reports as well as UDI database according to re-quirements.9.??????Provide expertise support to other departments, such as maintaining public share folder, label and IFU system, initial system, SAP system, etc.10.????Provide internal support, such as translation, payment, office supplies, CA, department seal, warehouse manage-ment as well as accomplishing the project assigned by operation leader or RACA head.

關于蔡司集團蔡司是全球光學和光電領域的技術先鋒。在2023/24財年，蔡司集團的全年營收達近110億歐元，覆蓋工業(yè)質量與研究、醫(yī)療技術、光學消費品、半導體制造技術四大業(yè)務部門（數(shù)據(jù)截至2024年9月30日）。目前，集團收入的15%用于科學和研發(fā)。蔡司致力于為客戶開發(fā)、生產(chǎn)和銷售前沿創(chuàng)新的工業(yè)測量及質保解決方案，針對生物及材料科學領域的顯微鏡解決方案，以及應用于眼科及顯微外科診療的醫(yī)療技術解決方案。蔡司也是全球光刻技術的行業(yè)標桿，其技術被芯片行業(yè)應用于半導體元件的制造。除此之外，蔡司品牌的眼鏡鏡片、相機鏡頭及望遠鏡等創(chuàng)新產(chǎn)品也適銷全球。憑借著符合數(shù)字化、醫(yī)療保健及智能制造等未來發(fā)展趨勢的產(chǎn)品組合，以及強大的品牌效應，蔡司正在塑造光學及其他相關領域的未來。蔡司在研發(fā)方面進行的可持續(xù)且大量的投入，為技術的不斷發(fā)展、市場的持續(xù)擴張和公司的未來成功都奠定了堅實的基礎。如今，蔡司集團在全球約50個國家擁有約46,500名員工。集團總部位于德國奧伯科亨?？柌趟竟煞莨居煽柌趟净饡Y所有，后者在德國致力于積極促進科學發(fā)展。歡迎訪問蔡司集團官方網(wǎng)站，了解更多信息。蔡司大中華區(qū)蔡司于1957年進入中國，目前在大中華區(qū)覆蓋半導體制造技術、工業(yè)質量解決方案、研究顯微鏡解決方案、醫(yī)療技術、視力保健和消費者光學所有業(yè)務領域。2021年起，中國已成為蔡司在全球最大的單一市場，也是最具創(chuàng)新活力、增長最快的市場之一。在2023/24財年，蔡司大中華區(qū)營收達151億元人民幣，實現(xiàn)同比增長12%。蔡司在大中華區(qū)共有7,000余位員工，分布于各地的22個生產(chǎn)基地、銷售與服務中心及研發(fā)中心，為本地客戶提供強有力的支持，也為全球各相關業(yè)務提供生產(chǎn)保障。蔡司大中華區(qū)總部位于上海自由貿易試驗區(qū)，設有銷售服務總部、應用服務與培訓中心、蔡司工業(yè)測量部生產(chǎn)工廠及蔡司集團在德國以外的首個企業(yè)級創(chuàng)新研發(fā)中心。蔡司上?？偛考皠?chuàng)新研發(fā)中心，協(xié)同蘇州研發(fā)制造基地、廣州知識城制造基地，逐步形成以高端光學鏡片、醫(yī)療耗材為主的產(chǎn)業(yè)鏈閉環(huán)，全面支持中國本土研發(fā)與生產(chǎn)，攜手本地合作伙伴共享高端產(chǎn)業(yè)可持續(xù)、高質量的發(fā)展機遇。更多信息，請參見蔡司中國官網(wǎng)。